Ipsen and Inspiration Biopharmaceuticals Announce That OBI-1 Has
Received Fast Track Designation from FDAfor Acquired Hemophilia A

Ipsen (Euronext: IPN, ADR: IPSEY) (Paris:IPN) and Inspiration
Biopharmaceuticals Inc. (Inspiration) today announced that Inspiration
has received Fast Track designation from the US Food and Drug
Administration (FDA) for OBI-1 in acquired hemophilia A. OBI-1, an
intravenous recombinant porcine factor VIII (FVIII), is being evaluated
for the treatment of individuals with acquired hemophilia A, who have
developed inhibitory antibodies (inhibitors) against their innate FVIII.

Fast track is a designation that the FDA reserves for a drug intended to
treat a serious disease and has a potential to fill an unmet medical
need. Fast track designation is designed to facilitate the development
and expedite the review of new drugs. Marketing applications for fast
track development programs are likely to be considered appropriate for
priority review, which implies an abbreviated review time of eight
months. Inspiration intends to submit a biologics license application
(BLA) to FDA in the first half of 2013.

OBI-1 received Orphan Drug Designation from the FDA in March 2004 and
from the European Medicines Agency (EMA) in October 2010.

About the first phase III clinical study in acquired hemophilia A

In November 2010, Inspiration initiated the first pivotal study of OBI-1
for the treatment of severe bleeding in individuals with acquired
hemophilia A. The pivotal phase III study is a prospective,
non-randomized, open-label study evaluating the efficacy of OBI-1 for
the treatment of serious bleeding episodes in individuals with acquired
hemophilia caused by development of autoimmune inhibitory antibodies to
human FVIII. Serious bleeding episodes include those that are a threat
to a patient’s life or vital organs or limbs, or which require a blood
transfusion. For more information on the OBI-1 Phase III pivotal study
for the treatment of individuals with acquired hemophilia, please visit http://clinicaltrials.gov/ct2/show/NCT01178294.

Results from the first 12 subjects in this clinical study were presented
during the World Federation of Hemophilia (WFH) Meeting in July 2012.
Enrollment in the OBI-1 acquired hemophilia A clinical trial is ongoing.

About OBI-1

In the fourth quarter of 2010, OBI-1 entered late-stage clinical testing
in individuals with acquired hemophilia, a rare, potentially
life-threatening bleeding disorder, which, unlike congenital hemophilia,
typically affects older adults and occurs equally in both males and
females. Further, Inspiration has initiated a second pivotal clinical
trial in individuals with congenital hemophilia A who have developed
inhibitors against human FVIII. OBI-1 provides clinicians with a unique,
alternative approach to address the needs of individuals who have
developed inhibitors to FVIII, and has been greeted with enthusiasm by
the medical community.

About Hemophilia

Hemophilia is a bleeding disorder caused by low levels or the absence of
a protein called a coagulation factor, essential for blood clotting. The
two most common forms of hemophilia are types A and B. Hemophilia A is
caused by a factor VIII deficiency and the congenital form occurs in ~1
out of every 5,000 male births. Acquired hemophilia A, a rare condition,
is caused by autoantibodies formed against the person’s own FVIII, often
brought on by an underlying medical condition mostly in the elderly
population. Hemophilia B is caused by a deficiency of coagulation factor
IX and occurs in ~1 out of every 30,000 male births. Approximately 60%
of persons with hemophilia have a severe condition, which results in
frequent spontaneous bleeding episodes, in addition to serious bleeding
after injuries. The annual market for hemophilia treatments is estimated
at $8 billion worldwide.

About the partnership agreement between Inspiration and Ipsen and the
product portfolio

In January 2010, Inspiration entered into a strategic agreement with
Ipsen, leveraging the combined expertise and resources of the two
companies, to develop a broad portfolio of hemophilia products and two
products in phase III. IB1001, an investigational intravenous
recombinant factor IX (rFIX) therapy for the treatment and prevention of
bleeding episodes in people with hemophilia B, and OBI-1, an
investigational intravenous recombinant porcine factor VIII (rpFVIII)
therapy for the treatment of patients with i) acquired hemophilia A and
ii) congenital hemophilia A who have developed inhibitors against human
FVIII.

In August 2011, Ipsen and Inspiration announced the extension of their
agreement to create a hemophilia business unit structure that will act
as the exclusive sales organization for all hemophilia products
commercialized under the Inspiration brand in Europe.

On 21 August 2012, Ipsen and Inspiration renegotiated their 2010
partnership. This agreement aimed to establish an effective structure
whereby Ipsen gained commercial rights in key territories. Inspiration
remains responsible for the world-wide development of OBI-1 and IB1001.
Ipsen paid Inspiration an upfront payment $30 million for these rights,
providing Inspiration with time to secure independent third party
financing and Ipsen with time to assess potential ways forward.

On 31 August 2012, Ipsen paid Inspiration $7.5 million and received a
warrant for 15% of Inspiration’s equity, which Ipsen later terminated in
October 2012.

Ipsen had agreed to pay Inspiration an additional $12.5 million if
Inspiration had raised third party financing by the contractual deadline
of 30 September 2012. Inspiration did not manage to raise external
funding by this contractual deadline.

On 30 October 2012, Inspiration filed for protection under Chapter 11 of
the United States Bankruptcy Code. Inspiration is seeking a strategic
buyer through a formal sale process. Ipsen will include the
commercialization rights obtained from Inspiration in August 2012 in the
sale, as well as Ipsen’s OBI-1 manufacturing facility in Milford,
Massachusetts.

About Ipsen

Ipsen is a global specialty-driven pharmaceutical company with total
sales exceeding €1.1 billion in 2011. Ipsen’s ambition is to become a
leader in specialty healthcare solutions for targeted debilitating
diseases. Its development strategy is supported by four franchises:
neurology / Dysport®, endocrinology / Somatuline®,
uro-oncology / Decapeptyl® and hemophilia. Moreover, the
Group has an active policy of partnerships. Ipsen's R&D is focused
on its innovative and differentiated technological platforms, peptides
and toxins. In 2011, R&D expenditure totaled more than €250 million,
above 21% of Group sales. The Group has total worldwide staff of close
to 4,500 employees. Ipsen’s shares are traded on segment A of Euronext
Paris (stock code: IPN, ISIN code: FR0010259150) and eligible to the
“Service de Règlement Différé” (“SRD”). The Group is part of the SBF 120
index. Ipsen has implemented a Sponsored Level I American Depositary
Receipt (ADR) program, which trade on the over-the-counter market in the
United States under the symbol IPSEY. For more information on Ipsen,
visit www.ipsen.com.

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